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出境医 / 临床实验 / Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer (C-SmartManage)
Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer (C-SmartManage)
Study Description
Brief Summary:
This is a one year study to develop and test a culturally-tailored, web-based cognitive behavioral stress management (CBSM) intervention for Latino sexual minority men living with both HIV and cancer. Sexual minority Latino men living with HIV and cancer experience a variety of health disparities related to their diagnoses, including higher distress. The project will be a pilot randomized trial, comparing culturally-tailored CBSM to standard CBSM for dually-diagnosed participants. The project will use a community-based participatory research approach, and the investigators have included (and will continue to include) LGBT-serving community partners in all phases of the research from study design to implementation and dissemination of findings. The proposed study will aid in attenuating health disparities among Latino sexual minority men living with HIV and cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV/AIDS Cancer | Behavioral: Cognitive behavioral stress management Behavioral: Culturally-tailored cognitive behavioral stress management | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer |
| Estimated Study Start Date : | August 1, 2021 |
| Estimated Primary Completion Date : | February 28, 2022 |
| Estimated Study Completion Date : | February 28, 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Standard CBSM
Participants will receive standard web-based cognitive behavioral stress management (CBSM) over 4 weeks.
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Behavioral: Cognitive behavioral stress management
The SmartManage CBSM intervention includes content that is of clinical relevance to sexual minority men dually diagnosed with HIV and cancer. Intervention content includes: co-management of HIV and cancer, strategies for self-advocacy, partnering with the health system and health providers, intimacy and disclosure concerns regarding both conditions, and contextual stressors (e.g., racial/ethnic minority status), stigmatization, assertiveness and communication skills, and self-efficacy in care coordination. Participants receive weekly 1.5 hour interactive group sessions online that focus on stress and self-management skill-building, and also receive access to didactic information regarding intervention content via the intervention website. Intervention length is 4 weeks.
Other Name: SmartManage
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Experimental: Culturally-tailored CBSM
Participants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 4 weeks.
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Behavioral: Culturally-tailored cognitive behavioral stress management
This intervention will be a version of SmartManage that is culturally-tailored for Latino populations.
Other Name: C-SmartManage
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Outcome Measures
Primary Outcome Measures :
- General Stress [ Time Frame: 4 weeks ]Perceived Stress Scale; items summed to create total score; total score range: 0-56; higher scores indicate worse outcome
- Disease-Related Distress [ Time Frame: 4 weeks ]Impact of Events Scale-Revised; items summed to create total score; total score range: 0-88; higher scores indicate worse outcome
- Health Related Quality of Life [ Time Frame: 4 weeks ]Functional Assessment of Cancer Therapy-General and Medical Outcomes Study-HIV Survey
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Cisgender males |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have been diagnosed with at least one form of non-metastatic solid tumor cancer,
- Are ≥ 30 days post active primary treatment (i.e. surgery, radiation, and/or chemotherapy*) for their cancer. (Note: Adjuvant therapies, such as hormone therapy for prostate cancer, etc. are not considered exclusionary),
- Self-identify as a sexual minority man,
- have been diagnosed with HIV,
- Have reliable access to a computer/device with internet accessibility, and
- Are fluent English.
Exclusion Criteria:
- Have had one of the following exclusionary cancer types: Leukemia (or other cancers of the blood), Non-melanoma skin cancer only (not in combination with another type listed in the inclusion criteria above), Brain cancer, Eye cancer, a form of pediatric cancer (if the pediatric cancer is the only cancer diagnosis the patient has had),
- Have a history of advanced (metastatic) cancer of any type or are currently undergoing primary treatment for their cancer,
- Have had inpatient treatment for severe mental illness in the past 12 months, or have overt signs of psychopathology (i.e. psychosis) and/or suicidality at the time of screening,
- Are experiencing active alcohol dependence, or have had inpatient treatment for alcohol abuse within the past 12 months,
- Are experiencing active substance dependence, or have had inpatient treatment for substance abuse within the past 12 months, and/or
- Have any other medical conditions resulting in a predicted life expectancy <12 months.
Contacts and Locations
Contacts
| Contact: Sara St. George, Ph.D. | 305-243-0726 | s.stgeorge@miami.edu |
Locations
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| Contact: Sara St.George, Ph.D. 305-243-0726 s.stgeorge@miami.edu | |
| Principal Investigator: Sara St.George, Ph.D. | |
Sponsors and Collaborators
University of Miami
Investigators
| Principal Investigator: | Sara St. George, Ph.D. | University of Miami |
| Tracking Information | |||||||
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| First Submitted Date ICMJE | June 19, 2019 | ||||||
| First Posted Date ICMJE | June 20, 2019 | ||||||
| Last Update Posted Date | April 29, 2021 | ||||||
| Estimated Study Start Date ICMJE | August 1, 2021 | ||||||
| Estimated Primary Completion Date | February 28, 2022 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer | ||||||
| Official Title ICMJE | Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer | ||||||
| Brief Summary | This is a one year study to develop and test a culturally-tailored, web-based cognitive behavioral stress management (CBSM) intervention for Latino sexual minority men living with both HIV and cancer. Sexual minority Latino men living with HIV and cancer experience a variety of health disparities related to their diagnoses, including higher distress. The project will be a pilot randomized trial, comparing culturally-tailored CBSM to standard CBSM for dually-diagnosed participants. The project will use a community-based participatory research approach, and the investigators have included (and will continue to include) LGBT-serving community partners in all phases of the research from study design to implementation and dissemination of findings. The proposed study will aid in attenuating health disparities among Latino sexual minority men living with HIV and cancer. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||
| Estimated Enrollment ICMJE |
50 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | February 28, 2022 | ||||||
| Estimated Primary Completion Date | February 28, 2022 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03993054 | ||||||
| Other Study ID Numbers ICMJE | 20200127 | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Sara StGeorge, University of Miami | ||||||
| Study Sponsor ICMJE | University of Miami | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | University of Miami | ||||||
| Verification Date | April 2021 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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